PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT— 510(k) K933930
Substantially EquivalentPuritan Bennett Corp.
FDA 510(k) clearance K933930 for PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT, Substantially Equivalent on 1994-03-21. Applicant: Puritan Bennett Corp.. Device class: 2.
Clearance details
- Applicant
- Puritan Bennett Corp.
- Product code
- Code BYJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5655
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Recent devices under product code BYJ
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- K022103 — PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
- K001646 — PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
Adverse events under product code BYJ
product code BYJ- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.